BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 17546952 · Received August 14, 2023

    Report

    Report Number
    9616657-2023-00033
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 31, 2023
    Report Date
    September 14, 2023
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 2062764. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. AS NEITHER PICTURE NOR PHYSICAL SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE DID NOT HAVE GRADUATION MARKINGS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: NO GRADUATION ON ONE OF THE SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE DID NOT HAVE GRADUATION MARKINGS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: NO GRADUATION ON ONE OF THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246609 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 2062764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown